Process/Product Validation Engineer (Medical Engineering)

Job description

Process/Product Validation Engineer (Medical Precision Engineering)Leeds£38,000 - £45,000 Negotiable + 25 days holiday + personal development plan + flexible working + pensionAre you a Validation Engineer looking to make their mark with a respected precision engineering business manufacturing some of the world's leading surgical instruments?Are you from a Medical Manufacturing or Pharmaceutical background looking to join a fast growing publicly quoted engineering business and make the role your own, being to go to person for the Quality and Safety of life-saving instrumentation?On offer is an opportunity to work for an engineering business supplying into the exciting surgical and medical markets worldwide and to develop and implement protocols to ensure the highest standards.The successful Process/Product Validation Engineer will be working on multiple projects and within various departments throughout the organisation. The candidate will work alongside R&D, Manufacturing, Quality Assurance, Quality Control, Production Planning of the business and will be the key member of the engineering team for all validation activities.You will be a self-motivated, self-starter that is able to work under your own initiative, whilst also working to tight deadlines. You will possess previous hands-on manufacturing experience with vast exposure to both validation and process improvement activities.The successful candidate will:Produce detailed Validation Plans, pFMEAs & participate in risk assessment activities in accordance with ISO 14971.The validation of manufacturing activities including IQ, OQ and PQ protocols and reports for new processes, components and finished devices.Appropriate retrospective validation activities to bring the products in line with CFR 820.Perform Gap Analysis on SI's Validation status and produce reports to track status and progress.Be the "go to" person for validation knowledge and updates.Project participation - Ensure NPI projects are transferred into manufacturing on time and to budget.Adhere to GDP and actively contribute to reviewing and maintaining all associated Validation and Verification documents including but not limited to: Technical Files & Design History Files (DHRs).Processing and Validation data analysis using Minitab software.Define, create and run detailed mechanical test programs and produce fully auditable technical reports.Assisting with the implementation of corrective actions surround in all validation activities following customer complaints and both internal and external NCR's/CAPA's.Review all current associated documentation against current regulatory requirements and plan/execute all corrective actions.Qualifications, Skills and ExperienceExperience in Validation in a Medical or Pharmaceutical environmentExperience of IQ, OQ and PQ protocolsThis is an excellent opportunity for someone looking to progress their career and to work with a reputable organisation supplying into the medical industryValidation Engineering Manager, Validation Engineering, Process & Product Validation, Validation Protocols, Leeds Validation Engineer jobsIf you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.Ernest Gordon Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job, you accept the T&C's, Privacy Policy and Disclaimers which can be found at our website.